Extension Study of MT-1303
Phase 2
Completed
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Interventions
- Drug: MT-1303-HighDrug: MT-1303-LowDrug: MT-1303-Middle
- Registration Number
- NCT01890655
- Lead Sponsor
- Mitsubishi Tanabe Pharma Corporation
- Brief Summary
To evaluate the long-term safety and tolerability of MT-1303 in subjects with relapsing remitting multiple sclerosis (RRMS).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 367
Inclusion Criteria
- Completion of the 24-week treatment period in MT-1303-E04 as per protocol
- Able to provide written informed consent and to comply with the requirements of the protocol
- For males and females of reproductive potential, two methods of contraception must be used throughout the study and for 12 weeks after cessation of study medication. At least one of the methods of contraception must be a barrier method.
Exclusion Criteria
- Permanent discontinuation of study medication prior to the end of treatment (EOT) visit in MT-1303-E04
- Newly diagnosed diabetes mellitus during MT-1303-E04
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MT-1303-High MT-1303-High MT-1303-High Dose MT-1303-Low MT-1303-Low MT-1303-Low Dose MT-1303-Middle MT-1303-Middle MT-1303-Middle Dose
- Primary Outcome Measures
Name Time Method Safety assessments Month 18 Adverse Events
- Secondary Outcome Measures
Name Time Method Clinical efficacy Month 18 Annualised relapse rate(ARR)
Magnetic Resonance Imaging (MRI) Month 18 Change and percent change in brain volume at EOT
Trial Locations
- Locations (1)
Research Site
🇬🇧City name, United Kingdom